Dual swab fluid sample collection for split sample testing and fingerprint identification device

ABSTRACT

An apparatus for testing a fluid sample including a sample receiving member having an opening for receiving a fluid sample, wherein the sample receiving member comprises at least a first and second sample collection chambers, a sample retention member, in fluid communication with the first sample collection chamber, to retain a portion of the fluid sample, and at least one test strip, in fluid communication with the second collection chamber, to indicate the presence or absence of at least one analyte in the fluid sample, wherein the first collection chamber is not in fluid communication with the second collection chamber.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional application of U.S. non-provisionalapplication Ser. No. 15/417,905, filed on Jan. 27, 2017.

BACKGROUND OF THE INVENTION 1. Field of the Invention

The present invention relates to substance collection and testing. Moreparticularly, the present invention relates to a device that tests afluid sample for the presence or absence of at least one analyte,secures a separate fluid sample for later confirmation, and providespositive identification of an individual associated with the sample. Inanother aspect, the present invention relates to a device for collectinga fluid sample.

2. Background

Drug and other analyte testing has become ubiquitous in modern society.In homes, doctors' offices, law enforcement vehicles and offices,athletic facilities, and the workplace, effective, inexpensive andreliable testing devices have been sought. There is also a growing needfor devices to test bodily fluids for substances that may assist in thediagnosis or management of diseases and other medical conditions.

The marketplace responded and is now replete with many devices directedto the testing of blood, urine or saliva. However, these devices mayrequire a series of tests involving the shifting of the fluid samplebeing tested to different containers and/or the removal of the fluidsample to distant locations. These devices may also require the testadministrator to handle the test subject's bodily fluids, incurring adanger of disease exposure.

Once an initial test result has been obtained, further testing of thesame fluid sample to confirm or refine the initial test result is oftenrequired. For a membrane test strip device, the fluid sample may noteven be retained once the initial result is obtained, necessitatingretention of a split sample. The need to retain a split sample incursthe risk that a sample could be lost, mislabeled, or contaminated.

Oftentimes, the chain of custody associated with a test sample imbuesthe results with doubt, as the fluid sample may become contaminated,misplaced or a different fluid sample may be substituted entirety. Inmany instances, identification of the test subject associated with thefluid sample is critically dispositive.

Prior art testing devices include those disclosed in U.S. Pat. Nos.7,879,623 and 8,940,527, both entitled “Integrated Device for Analyte,Testing, Confirmation, and Donor Identity Verification” and bothidentifying Raouf A. Guirguis as the sole inventor. U.S. Pat. Nos.7,879,623 and 8,940,527 are both hereby incorporated by reference. Thepatents disclose an apparatus for fluid sample collection and analytetesting, including a single sample receiving member and at least onemembrane test strip, and optionally a sample retention member,fingerprint acquisition pad, and/or fluid collector. It also provides afluid collection apparatus having an absorbent material, compressionelement, and closure element, and optionally a lid that allows theapparatus to be used in conjunction with a fluid container. Alsoprovided are methods of collecting, testing, and retaining a fluidsample and verifying the identity of one or more individuals associatedwith the sample, such as the test subject, test administrator, and/orwitnesses. The components for collecting, testing, and retaining a fluidsample are in fluid communication with the other components of thetesting device.

There is also a growing need for devices directed to testing forcontaminants that may be found in food or water, such as pollutants,allergens, and harmful microbes. In some instances, it may be desirableto retain a fluid sample for confirmation testing or further analysis,retain a split fluid sample of the original sample for confirmationtesting or further analysis, or to provide positive identification ofthe test administrator.

The Department of Transportation's (DOT) rule, 49 C.F.R. Part 40,describes required procedures for conducting workplace drug and alcoholtesting for the Federally regulated transportation industry. Within thisrule, definitions for split sample and split sample collection areprovided. Split specimen is defined as, in drug testing, a part of theurine specimen that is sent to a first laboratory and retained unopened,and which is transported to a second laboratory in the event that theemployee requests that it be tested following a verified positive testof the primary specimen or a verified adulterated or substituted testresult. Split specimen collection is defined as a collection in whichthe urine collected is divided into two separate specimen bottles, theprimary specimen (Bottle A) and the split specimen (Bottle B).

Thus, a need exists in the industry to combine the simplicity of currentmembrane test strip technology with the ability to positively identifythe test subject and/or the test administrator, as well as thecapability to secure a split portion of the fluid sample with a singledevice for later confirmation, within a single device.

BRIEF SUMMARY OF THE INVENTION

According to one embodiment, the invention provides an apparatus fortesting a fluid sample comprising: a sample receiving member having anopening for receiving a fluid sample, wherein the sample receivingmember comprises at least a first and second sample collection chambers;a sample retention member, in fluid communication with the first samplecollection chamber, to retain a portion of the fluid sample; and atleast one test strip, in fluid communication with the second collectionchamber, to indicate the presence or absence of at least one analyte inthe fluid sample; wherein the first collection chamber is not in fluidcommunication with the second collection chamber.

According to one embodiment, the invention provides an apparatus fortesting a fluid sample comprising: a sample receiving member having anopening for receiving a fluid sample; and a test cartridge member influid communication with the sample receiving member, to indicate thepresence or absence of at least one analyte in the fluid sample; thetest cartridge member comprising a test cartridge further comprisingdual sets of back-to-back test strips including a front set of teststrip slots and a back set of test strip slots.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and other advantages of this invention will become moreapparent by the following description of invention and the accompanyingdrawings.

FIG. 1 depicts a perspective view of a fluid collection and analytetesting device in accordance with an embodiment of the presentinvention.

FIG. 2 depicts a perspective view of a fluid collection and analytetesting device in accordance with an embodiment of the presentinvention.

FIG. 3 depicts a perspective view of a fluid collection and analytetesting device in accordance with an embodiment of the presentinvention.

FIG. 4 depicts a perspective view of a housing of a fluid collection andanalyte testing device in accordance with an embodiment of the presentinvention.

FIG. 5 depicts a perspective view of a test cartridge cap of a fluidcollection and analyte testing device in accordance with an embodimentof the present invention.

FIG. 6 depicts a front view of a dual surface test cartridge with teststrip holders back-to-back of a fluid collection and analyte testingdevice in accordance with an embodiment of the present invention.

FIG. 7 depicts a perspective view of a split sample (dual sample) fluidcollector of a fluid collection and analyte testing device in accordancewith an embodiment of the present invention.

FIG. 8 depicts perspective view of a fingerprint assembly of a fluidcollection and analyte testing device in accordance with an embodimentof the present invention.

FIG. 9 depicts a front view of a dual surface test cartridge with teststrips back-to-back of a fluid collection and analyte testing device inaccordance with an embodiment of the present invention.

FIG. 10 depicts a cross-sectional end view of a housing of a fluidcollection and analyte testing device in accordance with an embodimentof the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Analyte Screening

An embodiment of the present invention provides an analyte screeningdevice which includes a rapid screening, lateral flow chromatographicimmunoassay for the simultaneous, qualitative or quantitative detectionof analytes in a fluid sample. For example, without limitation, thefluid sample may be saliva, urine, blood, mucus, water, or fluid extractof a solid or a semi-solid, for example stool or mucus or liquid biopsy.The fluid sample may also be an environmental sample, for example,without limitation, soil, dust, water, plant matter, insect, animalmatter, or a fluid extract of any of the foregoing. The fluid sample mayalso be a food or beverage, for example, without limitation, a liquidbeverage, a liquid-containing food, or a fluid extract of a solid,semi-solid or powdered food or beverage. The fluid sample may alsocontain genomic or proteomic material for testing and analysis.

An embodiment of the invention includes at least one membrane teststrip, in fluid communication with a sample receiving member, able toindicate the presence or absence of at least one analyte above or belowa threshold concentration in the fluid sample using a lateral flowchromatographic assay.

In an embodiment of the invention, the lateral flow chromatographicassay is a competitive assay, in which an analyte in the fluid samplecompetes with a competitor for binding with an anti-analyte antibody.For example, the anti-analyte antibody may be labeled, and thecompetitor may be immobilized in the test region of the membrane teststrip. After the fluid sample reaches the dye region, it encounters thelabeled anti-analyte antibody. If the analyte is present in the fluidsample above a predetermined threshold concentration, the analyte willsaturate the binding sites of the labeled anti-analyte antibody;otherwise, some or the entire labeled anti-analyte antibody remains freeto bind the competitor. As the fluid sample migrates along the membranetest strip by capillary action, it carries the labeled anti-analyteantibody along until it reaches the test region. The test regioncontains the immobilized competitor, which may be the analyte, fragmentsof the analyte, epitopes of the analyte, molecular mimics of theanalyte, anti-idiotypic antibodies, or any other molecule able tocompete with the analyte for binding to the anti-analyte antibody. Ifthe analyte is present above the predetermined threshold concentration,the labeled anti-analyte antibody is saturated and does not bind theimmobilized competitor, resulting in no signal in the test region;otherwise, the anti-analyte antibody is unsaturated and can bind to thecompetitor, resulting in a signal in the test region.

Thus, according to an embodiment of the invention employing acompetitive assay, an analyte-negative fluid sample (containing lowerthan the predetermined concentration of the analyte) will generate aline in the test region due to capture of the labeled anti-analyteantibody, whereas an analyte-positive fluid specimen will not generate acolored line in the test region because the analyte in the fluid samplewill saturate the labeled antibody and thus prevent its capture in thetest region.

In an embodiment of the invention, the lateral flow chromatographicassay is a sandwich assay, in which the analyte must be present for thelabeled anti-analyte antibodies to be captured in the test region. Forexample, the analyte antibody may be a labeled antibody, and a secondanti-analyte antibody may be immobilized in the test region. Forexample, after the fluid sample reaches the dye region, it encountersthe labeled anti-analyte antibody. If the analyte is present in thefluid sample, it will bind at least a fraction of the labeledanti-analyte antibody. As the fluid sample migrates along the membranetest strip by capillary action, it carries the labeled anti-analyteantibody along until it reaches the test region. The test regioncontains an immobilized anti-analyte antibody, which may be reactiveagainst a different epitope of the analyte than the labeled anti-analyteantibody. If the analyte is present in the fluid sample, it forms ascaffold through which the labeled antibodies are immobilized in thetest region. The fraction of the labeled antibodies captured in the testregion is thus determined by the concentration of analyte in the fluidsample. If the analyte of interest is present above a predeterminedthreshold concentration, a sufficient fraction of the labeled antibodiesare captured, resulting in a visible signal in the test region;otherwise, an insufficient fraction of the antibodies are captured andno signal is visible in the test region.

Thus, according to an embodiment of the invention employing a sandwichassay, an analyte-positive fluid specimen will generate a colored linein the test region of the membrane test strip due to the capture of thelabeled antibody in the test region, whereas an analyte-negative fluidsample will not generate a fine in the test region due to failure tocapture the labeled antibody.

Embodiments of the invention include a positive control to indicate thatthe assay has functioned properly and is complete. For example, the dyeregion may include a labeled control protein, including withoutlimitation a labeled control antibody, and the control region of themembrane test strip may contain an immobilized control agent able tocapture the labeled control protein, such as an antibody or a controlanalyte. The control region may be located distal to each test region onthe membrane test strip, such that the fluid sample will encounter eachtest region before encountering the control region. The reaction of thelabeled control protein with the immobilized control agent produces acolored line in the control region, indicating that a proper volume ofthe fluid sample has been added and membrane wicking has occurred, andthe assay has worked properly.

An embodiment of the invention concurrently tests for multiple analytes,for example by employing membrane test strips capable of testingmultiple analytes concurrently (for example, by containing multipleanti-analyte antibodies in the dye region and having multiple compatibletest region), and/or by employing multiple membrane test strips withinthe same apparatus. An embodiment of the invention includes bothmembrane test strips that employ a competitive assay and a sandwichassay, for example on different membrane test strips within the deviceand/or on the same membrane test strip within the device.

Embodiments of the invention may provide quantitative determination ofthe concentration of an analyte that is present in the fluid sample. Forexample, the apparatus may include multiple membrane test strips havingvarying amounts of an anti-analyte antibody, resulting in varyinganalyte sensitivity, such that the concentration of the analyte isindicated by which of the membrane test strips show or fail to show acolored line in the test region.

Antibodies

An embodiment of the invention employs antibodies for the detection ofanalytes. The term “antibody” (Ab) as used herein includes monoclonalantibodies, polyclonal antibodies, multispecific antibodies (for examplebispecific antibodies), and antibody fragments, so long as they exhibitthe desired activity. The term “monoclonal antibody” as used hereinrefers to an antibody obtained from a population of substantiallyhomogeneous antibodies, that is, the individual antibodies comprisingthe population are identical except for possible naturally occurringmutations that may be present in minor amounts.

The terms “labeled antibody” and “labeled control protein” refer to anantibody or protein that is conjugated directly or indirectly to alabel. The label is a detectable compound or composition that may bedetectable by itself, Including without limitation a dye, colloidalmetal (including without limitation colloidal gold), radioisotope, orfluorescent compound, or, in the case of an enzymatic label, maycatalyze chemical alteration of a substrate compound or compositionwhich is detectable, or any combination of the foregoing.

Analytes

According to an embodiment of the invention, the apparatus includes adevice for testing a fluid sample for the presence of analytes. Thepresent invention contemplates testing for any analyte. Withoutlimitation, analytes that may be tested for include drugs of abuse ortheir metabolites, analytes indicating the presence of an infectiousagent or product of an infectious agent, allergen, pollutant, toxin,contaminant, analyte with diagnostic or medical value, antibody againstany of the foregoing, and any combination thereof.

According to an embodiment of the invention, analytes that may be testedfor include drugs of abuse and their metabolites, including withoutlimitation 7-acetaminoclonazepam, alkyl nitrites,alpha-hydroxyalprazolam, alprazolam,2-amino-2′-chloro-5-nitrobenzophenone, 7-aminoclonazepam,7-aminonitrazepam, amitriptyline, amobarbital, amoxapine, amphetamine,anabolid steroids, androgen, androstadienone, aprobarbital, atropine,barbiturates, benzodiazepines, benzoylecgonine, benzylpiperazine,boldenone undecylenate, 4-bromo-2,5-dimethoxyphenethylamine, bovinegrowth hormone, butabarbital, butalbital, butripryline,4-chlordehydromethyltesto sterone, chloroform, clomipramine, clonazepam,clostebol, cocaethylene, cocaine, codeine, codeine-6-glucuronide,cotinine, dehydroepiandrosterone, desipramine, desmethyldiazepam,desoxymethyltestosterone, dexmethylphenidate, dextroamphetamine,dextromethorphan, dextropropoxyphene, dextrorphan,2,5-diamino-2′-chlorobenzophenone, diamorphine, diazepam, dibenzepin,dihydrotestosterone, dimenhydrinate,2,5-dimethoxy-4-(n)-propylthiophenethylamine,2,5-dimethoxy-4-ethylphenethylamine, 2,5-dimethoxy-4-iodophenethylamine,dimethyl ether, dimethyltryptamine, dimethyltryptamine, diphenhydraminehydrochloride, dosulepin hydrochloride, dothiepin hydrochloride,doxepin, drostanolone, ecgonine, ecgonine methyl ester, ephedrine,ergine, estren, 5-estrogen,ethyl-5-(1′-methyl-3′-carboxypropyl)-2-thiobarbituric acid,5-ethyl-5-(1-′-methyl-3′-hydroxybutyl)-2-thiobarbituric acid,ethylestrenol, ethylphenidate, fentanyl, flunitrazepam, fluoxymesterone,furazabol, gamma-hydroxybutyrate, 1-(beta-D-glucopyranosyl) amobarbital,growth hormone, heroine, hexabarbital, human chorionic gonadotropin,human growth hormone, hydrocodone, hydromorphone,(+)-3-hydroxy-N-methylmorphinan, 3-hydroxy clonazepam,11-hydroxy-tetrahydrocannabinol (11-hydroxy-THC), 3′-hydroxyamobarbital,p-hydroxyamphetamine, p-hydroxynorophedrine, imipramine, iprindole,kava, katamine, levomethylphenidate, iofepramine, lorazepam,lorazepam-glucuronide, lysergic acid diethylamide, meperidine,mescaline, mestanolone, mesterolone, meta-chlorophenylpiperazine,methadone, methamphetamine, methandrostenolone, methcathinone,3,4-methylenedioxy amphetamine, methanolone, methanolone enanthate,methylenedioxymethamphelamine (ecstacy), methylphenidate,methylphenobarbital, methyl testosterone, mibolerone, (+)-3-morphinan,morphine, nandrolone, nicotine, nitrazepam, N-methyl-diethanciamine,norbolethone, norcodeine, norethandrolone, norketamine, nortriptyline,opiates, opipramol, opium, oxabolone opionate, oxandrolone, oxazepam,oxycodone, oxymetholone, oxymorphone, pentobarbital, phencyclidine,phenethylamines, phenobarbital, 4-phenyl-4-(1-piperidinyl)-cyclohexanol,1-phenyl-1-cyclohexene, phenylacetone,5-[N-(1-phenylcyclohexyl)]-aminopentanoic acid,1-(1-phenylcyclohexyl)-4-hydroxypiperidine, piperidine, protriptyline,psilocin, psilocybin, quinbolone, salvinorin A, scopolamine,secobarbital, sodium thiopental, stanozolol, telbutal, temazepam,testosterone, testosterone proprionate, tetrahydrocannabinol (THC),THC-COOH, tetrahydrogestrinone, toluene, trenbolone, tricyclicantidepressant, 3-trifluoromethylphenylpiperazine, trimipramine,tryptamines, or any combination thereof. The minimum concentration levelat which the presence of any particular drug or metabolite is detachedmay be determined by various industry minimum standards, such as, forexample, the National Institute on Drug Abuse (NIDA), the SubstanceAbuse & Mental Health Services Administration (SAMHSA), and the WorldHealth Organization (WHO).

According to an embodiment of the invention, analytes that may be testedfor include infectious agent or the products of an infectious agent,including without limitation Acanthamoeba, aflatoxin, alimentarymycotoxlcoses, altertoxin, amoeba, Anisakis, Ascaris lumbricoides,Bacillus arthracis, Bacillus cereus or its toxin, bacteria, bovinespongiform encephalopathy prioris, Brucella, Caliciviridae,Calymmatobacterium granulomatis, Campylobacter, Campylobacter jejuni,Candida, Candida albicans, Cephalosporium, Chlamydia trachomatis,chronic wasting disease prions, Citrinin, Clostridium botulinum or itstoxin, Clostridium perfringens, Corynebacterium ulcerans, Coxieliaburnetil, Creutzieldt-Jakob disease prions, Cryptococcus neoformans,Cryptosporidium, Cryptosporidium parvum Cycloplazonic acid, Cyclosperacayetanensis, Cytochaiasin, Cytomegalovirus, Diphyilobothrium,Escherichia Coli, Ebola, endotoxin, Entamceba histolytica, Enterovirus,Ergopeptine alkaloid, Ergot alkaloid, Ergotamine, Escherichia coli 0157,Eustrongylides, Fasciola hepatica, fatal familial insomnia prions,flatworm, Francisella tularensis, Fumitremorgen B.sub.1 Fumonisin,Fusarium, Fusarochromanone, genital warts,Gerstmann-Straussler-Scheinker syndrome prions, Giardia, Giardialamblia, Granuloma inguinale, H7 enterohemorrhagic, Haemophilus ducreyl,Helicobacter pylori, Hepatitis, Hepatitis A, Hepatitis B, Hepatitis C,Hepatitis D, Hepatitis E, Hepatitis E, herpes simplex virus, Histoplasmacapsulatum, HIV, HIV-1, HIV-2, human papillomavirus, influenza, Kaposi'ssarcoma-associated herpesvirus, Kojic acid, kuru prions, Listeriamonocytogenes, Lolitrem alkaloids, marburg virus, Methicillin-resistantStaphylococcus aureus or its toxin, molluscum, Moniliformin,mononucleosis, mycobacteria, Mycobacterium tuberculosis, Mycoplasma,Mycoplasma hominis, Mycotoxins, Myrothecium, Nanophyetus, Neisseriagonorrhosae, nematode, Nivalenol, Norovirus, Oohratoxins, Oosporeine,parasite, Patulin, Paxilline, Penitrem A, Phomopsins, Plasmodium,Platyhelminthes, Plesiomonas shigelloides, Penumococcus, Pneumocystisjirovecii, prions, protozoa, rhinovirus, Rotavirus, Salmonella,Sarcocystis hominis, Sarcocystis sulhominis, scraple prions, sexuallytransmitted disease, Shigella, Shigella, Sporidesmin A, Stachybotrys,Staphylococcus aureus or its toxin, Sterigmatocystin, Streptococcus,Streptococcus pneumoniae, Streptococcus pyogenes, Taenia saginata,Taenia solium, tapeworm, Tenia solium, Tinea, Toxoplasma gondii,Tremorgenic mycotoxins, Treponema palidum, Trichinella spiralis,Trichoderma, Trichomonas vaginalis, Trichothecene, Trichuris trichlura,Typanosoma cruzi, Ureaplasma urealyticum, Verrucosidin, Varruculogen,Vibrio cholerae non-O1, Vibrio cholerae O1, Vibrio-parahaemolyticus,Vibrio vulnificus, viruses, yeast infections, Yersinia enterocolitica,Yersinia pseudotuberculosis, Zearalenois, Zearalenone, antibodiesagainst any of the foregoing, or any combination thereof.

According to an embodiment of the invention, the analytes to be testedfor include allergens, including without limitation aesculus, aider,almonds, animal products, arternisia vulgaris, beans, bet sting venom,birch, calyx, cat dander, celeriac, celery, Chenopodium album,cockroach, corn, dander, dong dander, drugs, dust mite excretion, eggalbumen, eggs, Fei d 1 protein, fruit, fur, grass, hazel, hornbeam,insect stings, latex, legumes, local anaesthetics, maize, metal, milk,mold spores, mosquito saliva, mouse dander, nettle, olea, peanuts, peas,pecans, penicillin, Plant pollens, plantago, platanus, poplar, pumpkin,ragweed, rat dander, ryegrass, salicylates, seafood, sesame, sorrel,soy, soybeans, sulfonamides, tilia, timothy-grass, tree nuts, trees,wasp sting venom, weeds, wheat, willow, antibodies against any of theforegoing, or any combination thereof.

According to an embodiment of the invention, the analytes to be testedfor include pollutants, toxins, and contaminants, including withoutlimitation 1,2-Dibromoethane, acrylamide, aldehydes, arsenic, artificialgrowth hormone, asbestos, benzene, benzopyrene, carcinogens,dichloro-diphenyl-trichloroethane, formaldehyde, kepone, lead, mercury,methylmercury, nitrosamines, N-nitroso-N-methylurea, organochlorineinsecticides, pesticides, polychlorinated biphenyls, polychlorinateddibenzofurans, polychlorinated dibenzo-p-dloxins, recombinant bovinegrowth hormone, recombinant bovine somatotropin, toluene, vinylchloride, antibodies against any of the foregoing, or any combinationthereof.

According to an embodiment of the invention, the analytes to be testedfor include analytes with diagnostic or medical value, including withoutlimitation acid phosphatase, active-B 12, AFP, Alanine Aminotransferase,Alanine Aminotransferase, Albumin, Albumin BCG, Albumin BCP, AlkalinePhosphatase, Alpha-1 Antitrypsin, Alpha-1 Glycoprotein, Amikacin,Ammonia, Amylase, Anti-CCP, Anti-Tg, Anti-TPO, Apolipoprotein A1,Apolipoprotein B, ASO, Asparate Aminotransferase, AspartateAminotransferase, B12, Beta2 Microglobulin, Beta2 Microglobulin, BNP, CA125, CA 125 II, CA 15-3, CA 19-9 XR, Calcium, Carbamazepine, CarbonDioxide, CEA, Ceruloplasmin, Cholesterol, CK-MB, Complement C3,Complement C4, Cortisol, C-Peptide, C-Reactive Protein, Creatine Kinase,Creatinine, CRP Vario, Cyclosporine, Cyclosporine and Metabolite-WholeBlood, Cyclosporine Monoclonal-Whole Blood, D-Dimer, DHEA-S, Digitoxin,Digoxin, Digoxin, Digoxin II, Digoxin III, Direct Billirubin, DirectLDL, Estradiol, Ferritin, FLM II, Folate, Free Carbamazepine, FreePhenytoin, Free PSA, Free T3, Free T4, Free Valproic acid, FSH,Gamma-Glutamyl Transferase, Gentamicin, Glucose, Glycated Hemoglobin,Haptoglobin, hCG, Hemoglobin, Homocysteine, ICT CI-, IGFBP-1,Immunoglobulin, Immunoglobulin A, Immunoglobulin E, immunoglobulin G,Immunoglobulin M, Insulin, Intact PTH, Iron, K+, Kappa Light Chain,Lactate Dehyrogenase, Lactic acid, Lambda Light Chain, LH, Lidocaine,Lipase, Lithium, Lp, magnesium, metabolites, Methotrexate II,Microalbumin, MPO, Myoglobin, Na+, N-Acetyl-procainamide, neonatalBillirubin, NGAL, P-Amylase, Pepsinogen I, Pepsinogen II, Phenobarbital,Phenytoin, Phosphorus, Prealbumin Procainamide, Progesterone, Prolactin,Quinidine, Rheumatoid Factor, SHBG, Sirollmus, STAT CK-MB, T4,Tacrolimus, Tacrolimus II, Testosterone, Tg, Theophylline, TheophyllineII, TIBC, TIMP-1, Tobramycin, Total Billirubin, Total Estriol, TotalProtein, Total PSA, Total T3, Total T4, Transferrin, Triglycerides,Troponin-I, Troponin-I ADV, TSH, T-Uptake, UIBC, Ultra HDL, UreaNitrogen, Uric Acid, Urine/CSF Protein, Valproic Acid, Vancomycin,Vancomycin II, Vitamin D, antibodies against any of the foregoing, orany combination thereof.

Receiving Member

According to an embodiment or the invention, the apparatus includes areceiving member, having an opening to receive a fluid sample, Forexample, the receiving member may be dimensioned to receive a fluidcollector. In an embodiment of the invention, the receiving member maybe in fluid communication with other components of the apparatus, forexample at least one membrane test strip, sample retention member,and/or an Immunoassay-based fingerprint acquisition pad, throughchannels, for example tubes, piping, channels molded or carved into theapparatus, or any other suitable structure, made of any suitablematerial, for example plastic, ceramic, metal, glass, wood, rubber,polymer, fiber-reinforced polymer, or any combination thereof.

According to an embodiment of the invention, the channel or channelsproviding fluid communication between the components may have differingflow resistance, for example having channels, channel segments, oropenings, that are narrower, wider, longer, or shorter than others,and/or having fluid paths with varying amounts of vertical rise or drop,such that the fluid channels within the device have varying degrees offlow resistance. For example, the channel that provides the fluidcommunication of the sample receiving member with the at least onemembrane test strip may have greater flow resistance than the at leastone channel that provides the fluid communication of the samplereceiving member with the sample retention member, to ensure that aportion of the fluid sample is collected in the sample retention member.

In an embodiment of the invention, a single channel having multipleopenings may connect the receiving member to each of the components ofthe apparatus with which it is in fluid communication, for example theat least one membrane test strip, sample retention member, and/orimmunoassay-based fingerprint acquisition pad.

In an embodiment of the invention, the receiving member may include twoor more chambers for receipt of a multi-pronged fluid collector,including but not limited to a dual-swab fluid collector. Components ofthe apparatus may be solely connected to one of the multiple chambers.For example, in a two chamber embodiment, one chamber may be solelyconnected to a sample retention member to ensure that a portion of thefluid sample is collected and stored without interaction of the othercomponents of the apparatus.

An embodiment of the invention may accommodate fluids of varyingviscosity, for example water, saliva, urine, blood, and liquidsassociated with genomics and proteomics. Generally, this is accomplishedby varying the diameter of the channel or channels that provide thefluid communication of the sample receiving member with the othercomponents of the apparatus, for example providing a wider channeldiameter to accommodate a more viscous fluid.

In an embodiment of the invention, a channel dimensioned to becompatible with a fluid having the viscosity of water provides the fluidcommunication of the sample receiving member with the at least onemembrane test strip and at least one channel dimensioned to becompatible with a fluid having the viscosity of water provides the fluidcommunication of the sample receiving member with the sample retentionmember.

In an embodiment of the invention, a channel dimensioned to becompatible with a fluid having the viscosity of urine provides the fluidcommunication of the sample receiving member with the at least onemembrane test strip and at least one channel dimensioned to becompatible with a fluid having the viscosity of urine provides the fluidcommunication of the sample receiving member with the sample retentionmember.

In an embodiment of the invention, a channel dimensioned to becompatible with a fluid having the viscosity of saliva provides thefluid communication of the sample receiving member with the at least onemembrane test strip and at least one channel dimensioned to becompatible with a fluid having the viscosity of saliva provides thefluid communication of the sample receiving member with the sampleretention member.

In an embodiment of the invention, a channel dimensioned to becompatible with a fluid having the viscosity of blood provides the fluidcommunication of the sample receiving member with the at least onemembrane test strip and at least one channel dimensioned to becompatible with a fluid having the viscosity of blood provides the fluidcommunication of the sample receiving member with the sample retentionmember. In an embodiment of the invention, a channel dimensioned to becompatible with a fluid having the viscosity of mucus provides the fluidcommunication of the sample receiving member with the at least onemembrane test strip and at least one channel dimensioned to becompatible with a fluid having the viscosity of mucus provides the fluidcommunication of the sample receiving member with the sample retentionmember.

In an embodiment of the invention, a channel dimensioned to becompatible with a fluid having the viscosity of liquid associated withcell separation provides the fluid communication of the sample receivingmember with the at least one membrane test strip and at least onechannel dimensioned to be compatible with a fluid having the viscosityof liquid associated with cell separation provides the fluidcommunication of the sample receiving member with the sample retentionmember.

In an embodiment of the invention, a channel dimensioned to becompatible with a fluid having the viscosity of liquid biopsy, such asproteomics or genomics, provides the fluid communication of the samplereceiving member with the at least one membrane test strip and at leastone channel dimensioned to be compatible with a fluid having theviscosity of liquid biopsy provides the fluid communication of thesample receiving member with the sample retention member. Proteomics isthe study of proteins. Genomics is a branch of molecular biologyconcerned with the structure, function, evolution, and mapping ofgenomes.

In an embodiment of the invention, the receiving member may have aninner surface, for example a lower surface, that an absorbent material,such as an absorbent material present in a fluid collector, may becompressed against, thereby expelling the fluid sample from theabsorbent material. For example, the absorbent material may becompressed directly between a compression member present on the fluidcollector and the lower surface of the receiving member or the receivingmember may provide structural support to facilitate compression of theabsorbent material between a compression member and the housing that atleast partially surrounds the absorbent material.

Sample Retention Member

According to an embodiment of the invention, the apparatus includes asample retention member. The sample retention member may be used tosecurely contain a portion of the fluid sample, such as a split sample.The retained portion of the fluid sample may be used for furthertesting, for example for confirmation of a test result obtained using amembrane test strip, or to test for the presence or absence of otheranalytes in the fluid sample. The retained portion of the fluid samplemay also be used for confirmation of the test subject's identity throughanalysis of a distinguishing feature thereof, including withoutlimitation DNA, cells, proteomics, metals, and liquid biopsy.

According to one embodiment of the invention, the sample retentionmember includes an absorbent material, for example a pad or sponge, ormade of woven or non-woven fibrous or fabric-like material, for examplecellulose or a cellulose derivative, cotton, hydrophilic foam, woodpulp, polyvinyl alcohol fibers, or any combination thereof. The sampleretention member may include an absorbent material that is part of thesample collection apparatus. The absorbent material may be surrounded bya barrier, such as a liquid-impermeable material, including withoutlimitation plastic, ceramic, metal, glass, wood, rubber, polymer,fiber-reinforced polymer, or any combination thereof, to prevent theretained sample from leaking or evaporating. In an embodiment of theinvention, the absorbent material may be removably attached to theapparatus to facilitate retrieval of the retained fluid sample. In anembodiment of the invention, the absorbent material may be accessedusing a needle, for example by piercing a barrier surrounding theabsorbent material. The retained sample may then be removed, forexample, into a syringe attached to a needle, by means of withdrawal ofthe syringe to create suction.

According to an embodiment of the invention, the sample retention memberincludes a storage container defining a volume for storage of the fluidsample. In one embodiment of the invention, the sample retention membermay be a vial made from a breakable or nearly unbreakable material,including without limitation glass, plastic, ceramic, metal, metal foil,wood, rubber, polymer, fiber-reinforced polymer, or any combinationthereof. In an embodiment of the invention, the storage container may beaccessed using a needle to pierce the wall of the storage container. Forexample, the storage container may include a pierceable member, such asa region of decreased wall thickness, and/or made of a soft, pierceable,or breakable material, including without limitation plastic, ceramic,metal, glass, metal foil, wood, rubber, polymer, fiber-reinforcedpolymer, or any combination thereof, that may be pierced. The retainedsample may then be removed, for example, into a syringe attached to aneedle, by means of withdrawal of the syringe to create suction. In anembodiment of the invention, the storage container may be removablyattached to the apparatus, including without limitation, through a lineof weakness that may allow the storage container to be broken free formthe apparatus, through a threaded connection mechanism between thesample retention member and the fluid sample testing device, or througha twisting lock connection mechanism between the sample retention memberand the fluid sample testing device.

According to an embodiment of the invention, the removable sampleretention member may be linked to or coded consistently with the fluidsample testing device, including but not limited to, identical orrelated identification or serial numbers on both the sample retentionmember and the fluid sample testing device, identical or related barcode information on both the sample retention member and the fluidsample testing device, and the inclusion of radio frequencyidentification devices (RFID) on the sample retention member or thesample retention member and the fluid sample testing device. RFIDincorporates the use of electromagnetic or electrostatic coupling in theradio frequency (RF) portion of the electromagnetic spectrum uniquelyidentify an object; such unique identification information may beinformation specific to the sample provider or information unique to thefluid sample testing device.

According to an embodiment of the invention, the sample retention membercontains substances that facilitate a further use of the sample,including without limitation preservatives of stabilizers able topreserve sample integrity, for example substances able to inhibitmicrobial growth, kill microbes, prevent sample leakage, prevent sampleevaporation, inhibit chemical or enzymatic degradation of substances inthe sample, support survival of cells or other microbes in the sample,or any combination thereof.

According to an embodiment of the invention, the sample retention membermay be bonded to a fingerprint acquisition pad. For example, such a bondmay provide a safeguard against dissociation of the retained sample fromthe fingerprint.

According to an embodiment of the invention, the sample retention membermay be in fluid contact solely with the sample receiving member and maynot have any fluid contact with any other component of the apparatus.

The retained fluid sample may be used for further confirmation testing,including without limitation gas chromatography, liquid chromatography,mass spectrometry, liquid or gas chromatography with tandem massspectrometry, polymerase chain reaction, DNA sequencing, Enzyme-LinkedImmunoSorbent Assay, Western Blotting, culturing for growth, or anycombination thereof, using the retained fluid sample.

Fluid Collector

An embodiment of the apparatus comprises a fluid collector forcollecting a fluid sample. The present invention contemplates collectinga sample from a specific subject, such as a human subject, or testingenvironmental samples, such as testing air, water, soil, or some othersubstance, or a food or beverage, or a liquid extract of any of theforegoing for example, without limitation. The fluid collector isoperative associated with the apparatus. The fluid collector may beremovably associated with the apparatus/affixed to the apparatus, orcomprise multiple units of which one or more is affixed or removablyassociated with the apparatus.

In an embodiment of the invention, the fluid collector includes anabsorbent material or swab capable of absorbing a desired quantity of afluid sample. The absorbent material may be made of any suitablematerial known to a person in the art, for example, without limitation,a pad or sponge, or woven or non-woven fibrous or fabric-like material,including without limitation cellulose or a cellulose derivative,cotton, hydrophilic foam, wood pulp, polyvinyl alcohol fibers, or anycombination thereof. In an embodiment of the invention, the fluidcollector includes a compression member, able to compress the absorbentmaterial, that may be used to expel air from the absorbent materialprior to collection of the fluid sample and/or encourage the fluidsample to flow into the absorbent material by creating suction as thecompressed absorbent material returns to the uncompressed state. Acompression member may also be used, for example, to compress theabsorbent material and expel a fluid sample contained therein.

In one embodiment of the invention, the fluid collector includesmultiple collection swabs. For example, a two-prong fluid collector withdual swabs may be implemented to collect the sample. In one embodiment,each swab of a multi-swab fluid collector may be selected based upon thespecific swab collection characteristics. For example, in a dual-swabfluid collector, each swab may contain a material to assist in thecollection of different samples such as the collection of different cellmaterial.

A sufficiency indicator on the collector is contemplated. For examplewithout limitation, a color indicator may either appear or disappearwhen a sufficient sample has been collected, for example when asufficient volume has been absorbed to reach the location in theabsorbent material where the sufficiency indicator is disposed.According to an embodiment of the invention, the sufficiency indicatormay be operatively associated with the absorbent material and mayprotected from direct contact with the source of the fluid sample by abarrier, such as a transparent barrier, for example plastic or glass,such that the fluid sample will only reach the sufficiency indicator bypassing into the absorbent material.

The sufficiency indicator color may be in the shape of a word or symbolthat appears or disappears when a sufficient sample has been collected.For example, the sufficiency indicator may a diffusible dye, whereindilution of the dye by the fluid sample causes a color to disappear,indicating that a sample of sufficient volume has been collected. In anembodiment of the invention, a combination of a non-diffusible anddiffusible dye may be used together, such that the non-diffusible dyeremains and provides an informative message when the diffusible dyedisappears, for example the diffusible dye may form the letters “in” inthe word “insufficient” such that the non-diffusible dye remains andforms the word “sufficient” when a sufficient sample has been collected.

The sufficiency indicator may be a pH-sensitive substance that changescolor when the sample is encountered. For example, multiple pH sensitiveindicators responding to different pH values may be preset, such that acolor change is observed whether the sample is acidic, basic, orneutral. According to an embodiment of the invention, a pH-changingsubstance, such as an acid or base, may be disposed within the absorbentmaterial, such that the sample will be of the correct pH to elicit thedesired color change in the sufficiency indicator.

A closure member may be used. The closure member is capable of sealingthe open end of a sample receiving member when the fluid collector isinserted into the open end of a sample receiving member. For example,the closure member may be dimensioned to fit closely in the opening inthe open end of the receiving member, and the closure member or the openend of the receiving member may include a compressible material,including without limitation natural rubber such as vulcanized rubber,synthetic rubber such as neoprene or nitrite rubber, plastic, ceramic,or any combination thereof, disposed at the interface between theclosure member and the opening in the open end of the sample receivingmember, capable of creating a seal, such as an airtight or a watertightseal, when the sample receiving member receives the fluid collector.

After the fluid collector has been inserted into the sample receivingmember, a device for securing the fluid collector within the samplereceiving member is contemplated. The means for securing may preventremoval of the fluid collector from the sample receiving member after ithas been inserted therein. The means for securing the fluid collectorwithin the sample receiving member may include at least one projectionextending from the fluid collector that cooperates with the at least oneprojection located on the inner surface of the sample receiving member,where such projections may include for example at least one locking taband/or at least one annular ring. According to an embodiment of theinvention, a closure member on the fluid collector may form asufficiently secure closure as to constitute means for securing thefluid collector within the sample receiving member.

The sample receiving member may also include a tamper-evident seal, suchthat attempting to tamper with the contents of the apparatus will resultin a visual indicator, for example by tears or breakage visible in animprinted seal, for example tape or adhesive-backed foil havingcharacters, symbols or a signature on a surface. Such a tamper-evidentseal may be placed on the apparatus before its use, to create a visualconfirmation that the intents of the apparatus have not been altered viathe open end of the receiving member prior to testing, or after its use,to create a visual confirmation that the contents of the apparatus havenot been altered via the open end of the receiving member subsequent totesting. According to an embodiment of the invention, the means forsecuring the fluid collector within the sample receiving member mayconstitute a tamper evident seal, in that attempted removal of the fluidcollector from the sample receiving member after it has been insertedtherein may result in visible damage to the apparatus.

According to an embodiment of the invention, the fluid collectorincludes a handle, for example made of wood, plastic, ceramic, or metal,and disposed, for example, at the end distal to the absorbent material.The handle may be removably attached, for example through aninterference fit, adhesive, glue, or epoxy, that breaks or separateswhen the handle is twisted and/or pulled, or by a structure that allowsthe handle to be broken away, for example, a line of weakness.

The fluid collector may include a housing that at least partiallysurrounds the absorbent material. The housing may have multiple openingsto allow the fluid sample to be absorbed by and expressed from theabsorbent material. The openings in the housing may contain filtrationmembers able to strain particulates from the fluid sample, resulting inreduction of the number of particulates that enter the absorbentmaterial. The fluid collector may include a compression member able tocompress the absorbent material against the housing. For example, thehousing may be slideably coupled to a compression member with theabsorbent material disposed between the compression member and an innersurface of the housing, such that the absorbent material may becompressed by movement of the compression member towards an innersurface of the housing. An embodiment of the invention includes meansfor securing the absorbent material in the compressed state, includingwithout limitation cooperating threads, projections, and/or groovesoperatively associated with the compression member and the housing. Theabsorbent material may be released from the compressed state before,concurrently with, or after encounter with the fluid sample,facilitating entry of the fluid sample into the absorbent material asthe absorbent material returns to the relaxed state, creating suction.For example, the absorbent material may be operatively associated with aspring, such that compression of the absorbent material results incompression of the spring, and when compression is released the springassists return of the absorbent material to the uncompressed state.

In an embodiment of the invention, the fluid collector is operativelyassociated with the lid of a fluid container including withoutlimitation a urine cup. For example, the absorbent material may bedisposed on the inner side of the lid, such that attachment of the lidto the fluid container results in contact between the absorbent materialand a fluid sample. In certain embodiments of the invention, a portionof the fluid collector including the lid may be removably associatedwith a portion of the fluid collector including the absorbent material,allowing the absorbent material to be separated from the lid. Theoperative association of the fluid collector with the lid may includemeans for arresting the rotation of part of the fluid collector relativeto the lid, including without limitation cooperating projections presenton one member and grooves or slots present on the other member, forexample to facilitate release of means by which the absorbent materialis fixed in the compressed state.

Saliva Producing Substances

Use of a saliva producing substance is contemplated by the presentinvention. Saliva producing substances elicit or increase salivaproduction in the test subject. For example, without limitation, thesaliva producing substance may sugars, salts, acids, or any combinationthereof. In an embodiment of the invention, the saliva producingsubstance may be associated with a fluid collector, for example locatedon or in the absorbent material or the housing. In an embodiment of theinvention, the saliva producing substance may be separated from thefluid collector, for example in the form of a gum, candy, or powder, foradministration to the test subject before, during or after the fluidcollector is inserted into the test subject's mouth.

For example, without limitation, the sugar may be a monosaccharide, adisaccharide, a trisaccharide, an oligosaccharide, a polysaccharide,acarbose, allose, altrose, amylose, arabinose, calibiose, cyclodextrin,alph-cyclodextrin, beta-cyclodextrin, gamma-cyclodextrin, deoxyglucose,dextrin, dihydroxyacetone, erythrose, erythrulose, ficoli,fructo-oligosaccharides, fructose, galacto-oligosaccharides, galactose,gentiobiose, glucoasmine, glucose, glyceraldehyde, glycogen, gulosse,idose, inositol, inulin, isomaltose, lactose, lyxose, maltose,maltosyl-cyclodextrin, malt-trifose, mannan-oligosaccharides,mannoheptulose, marinose, melexltose, monnitol, psiccae, raffinose,ribitol, ribose, ribulose, sedoheptulose, sorbitol, sorbose, sucrose,tagatose, talose, threose, trehalose, xylose, xylulose, or anycombination thereof.

For example, without limitation, the salt may an inorganic salt, organicsalt, acid salt, alkali salt, neutral salt, or amino acid salt, or anycombination thereof. The salt may include a cation and an anion, forexample without limitation thereto, the cation may be aluminum,ammonium, barium, beryilium, calcium, cesiu, chromium(II),chromium(III), chromium(IV), cobalt(II), cobalt(III), copper(I),copper(II), copper(III), gallium, helium, hydrogen, hydronium, iron(II),iron(III), lead(II), lead(IV), lithium, magnesium, manganese(II),manganese(III), manganese(IV), manganese(VII), nickel(II), nickel(III),nitronium, potassium, pyridinium, silver, sodium, strontium, tin(II),tin(IV), zinc, or any combination thereof, and an anion may be acetate,amide, tartrate, borate, bromate, bomide, carbonate, chlorate, chloride,chlorile, chromate, citrate, cyanate, dichormate, dihydrogen phosphate,fluide, formate, glutamate, hydride, hydrogen carbonate, hydrogenoxalate, hydrogen phosphate, hydrogen sulfate, hydrogen sulfite,hydroxide, hypobromite, hypochlorite, iodate, iodide, nitrate, nitride,nitrite, oxalate, oxide, perchlorate, permanganate, peroxide, phosphate,phosphide, phosphite, pyrophosphate, sulfate, sulfide, sulfite,telluride, thiocyanate, thiosulfate, or any combination thereof. Forexample, according to an embodiment of the invention, the salt may besodium chloride or potassium chloride.

The acid may be any suitable acid known to a person skilled in the art,for example acetic acid, acrylic acid, adipic acid, alginic acid,alkanesulfonic acid, amino acid, asorbic acid, benzoic acid, boric acid,butyric acid, carbonic acid, carboxylic acid, citrio acid, fattys acid,folic acid, formic acid, fumaric acid, gluconic acid, hdyriodic acid,hydrobromic acid, hydrochloric acid, hydroquinosulfonic acid,isoascorbic acid, lactic acid, maleic acid, malio acid, malonic acid,methanesulfonic acid, nitric acid, oxalic acid, p-toluenesulfonic acid,para-bromophenylsulfonic acid, phosphoric acid, propionic acid,salicyclic acid, stearic acid, succinic acid, sulfuric acid, tannicacid, tartaric acid, thioglycolic acid, toluenesulfonic acid, uric acid,or any combination thereof.

Fingerprint Identification

An embodiment of the present invention includes a fingerprint pad toprovide identification of an individual associated with the test, suchas the test subject, test administrator, and/or one or more witnesses.The fingerprint pad may employ any suitable fingerprinting methodology,for example, without limitation, ink-based, immunoassay-based,electronic, semi-inkless, or inkless. In an embodiment of the invention,the fingerprint pad may be able to collect multiple fingerprints, forexample having multiple fingerprint pads, having one fingerprint pad ofsufficient size to accommodate multiple fingerprints, or having anelectronic fingerprint pad.

The fingerprint pad may be an ink-based fingerprint pad. An embodimentof the invention includes a dispenser able to dispense an ink that canelicit a signal in the ink-based fingerprint pad. The fingerprint padmay also be inkless or semi-inkless, for example requiring no ink orcompatible with an activator that appears transparent on the subject'sskin, is readily cleaned off the subject's skin, or readily disappears,for example, when the subject's hands are rubbed together. According toan embodiment of the invention, the inkless fingerprint pad may beimmunoassay-based, for example as described within U.S. Pat. No.6,352,663 to Raouf A. Guirguis, issued Mar. 5, 2002 (the “'863 patent”),and U.S. Pat. No. 5,244,815 to Raouf A. Guirguis, issued Sep. 14, 1993(the “'815 patent”), which are incorporated herein by reference in theirentirety. The immunoassay-based fingerprint pad may or may not be influid communication with a sample receiving member. Other embodiments ofthe invention may incorporate various features of the embodimentsdisclosed within the '863 and '815 patents. In embodiment of theinvention having an inkless or semi-inkless fingerprint pad thatrequires an activator to elicit a signal, the apparatus may also includea dispenser to dispense the activator. According to an embodiment of theinvention, the fingerprint pad may have a surface, such as an absorbentor adhesive surface, able to gather sweat, oils, and/or skin cells whena finger is pressed against it, that may require further processing topermit clear visualization of the fingerprint.

According to an embodiment of the invention, an inkless fingerprint padmay be an electronic fingerprint pad, including without limitation anoptical scan fingerprint reader or a solid-state fingerprint reader. Anembodiment of the invention includes a memory element, including withoutlimitation volatile or non-volatile memory, for example a hard disk,floppy disk, magnetic tape, optical disk, flash memory, holographicmemory, EEPROM, RAM, DRAM, SDRAM, or SRAM coupled to the fingerprint padfor storage of one or more fingerprints. According to an embodiment ofthe invention, the electronic fingerprint pads may have electricallycharged surface elements, wherein portions of the surface areelectrically discharged upon contact with the finger surface, such asthe ridges of the finger surface, such that the fingerprint is recordedin the pattern of discharged elements, whereby the fingerprint patternmay be stably stored within the surface for a time after it is createduntil it is read, for example through connection of the apparatus withan external device, including without limitation a base station. Anembodiment of the invention include means of transmission of thecaptured fingerprint, for example to an external device or network,including without limitation through a hard-wired connection, forexample employing wires, cables, or a docking station or dockingconnector, for employing a connection including without limitation USB,IEEE 1394, serial, parallel, or SCSI, or a wireless connection, forexample employing infrared, RF, IEEE 802.11, Bluetooth, IEEE 802.15, orWi-Fi.

In an embodiment of the invention, a cover encloses the fingerprintacquisition pad. The cover may be secured using various mechanisms, forexample, without limitation, a tab-and-slot connector, latch, springlatch, adhesive tape, or security tape. The cover may be secured priorto fingerprint acquisition and/or after fingerprint acquisition.

Referring to FIGS. 1-10, a fluid collection and analyte testing deviceaccording with embodiments of the invention are shown. In oneembodiment, an analyte testing device 800 includes a fluid collector812, to collect a fluid sample from a test subject, and a housing 801 totest and retain the fluid sample. The fluid collector 812 may includesingle or multiple collectors for the collection of the fluid sample. Inone embodiment of the invention, a dual-swab split sample testingdevice, the fluid collector 812 includes a dual collector or a two-prongcollector with prongs that are substantially identical, however, a widevariety of modifications to the prongs may be implemented withoutdetracting from the spirit of the invention, including but not limitedto, prongs of varying size, shape and materials. Each prong of the fluidcollector 812 includes an upper segment 820 having an upper surface, aclosure member 814, and sealing members 880; a compression member 890;and a collector 816 made from an absorbent material. A wide variety ofabsorbent materials capable of acquiring and storing a fluid sample maybe used without detracting from the spirit of the invention, includingbut not limited to a swab, a sponge, and a material that dissolvessubsequent to collection of the sample. In one embodiment of theinvention, the absorbent material may be saturated with asaliva-producing substance to aid in the collection of the fluid sample.Additionally, the collector 816 may include a sufficiency or visualindicator to indicate when a sufficient amount of the fluid sample ispresent in the collector 816. U.S. Pat. No. 9,198,641 entitled “SpecimenSample Collection System” describes one prior art sufficiency or visualindicator system and is hereby incorporated by reference. The fluidcollector 812 receives a fluid sample from a test subject andtemporarily stores the fluid sample until it is transferred to thehousing 801. In one embodiment of the invention, the fluid collector 812receives a fluid sample from a test subject to be used in a split samplefluid testing device.

One advantage of the inventions disclosed herein is the limited amountof test material needed for testing and retention. According to oneembodiment of the invention, only four hundred eighty (480) microlitersare required for the successful analysis of twelve (12) test strips,forty (40) microliters for each test strip and only seven hundred (700)microliters are required from each prong. The minimum retention amountnecessary is approximately the same volume as needed for the teststrips. This quantity of a sample is obtainable through the fluidcollector described herein. For example, forty (40) by ten (10)millimeter cylindrical collectors 816 collected a fluid, as the testsample, in amounts set forth in the tables below.

TABLE 1 Single-Prong Sample Collection Amount Total Fluid in FluidChamber Amount after Fluid Collection Collected Extraction Loss TimeSample (ml) (ml) (ml) (seconds) 1 1.7 1.23 0.47 67 2 1.5 1.13 0.37 89 31.66 1.31 0.35 73 4 1.48 1.11 0.37 105 5 1.36 1.04 0.32 114 6 1.71 1.290.42 101 7 1.65 1.33 0.32 113 8 1.36 1.03 0.33 97 Average 1.55 1.18 0.3795

TABLE 2 Dual-Prong Sample Collection Amount Total Fluid in 1^(st) Fluidin 2^(nd) Fluid Chamber Chamber Amount after after Fluid CollectionCollected Extraction Extraction Loss Time Sample (ml) (ml) (ml) (ml)(seconds) 1 3.67 1.01 1.34 1.32 106 2 3.07 1.07 1.08 0.92 128 3 3.231.22 1.10 0.91 145 4 2.92 1.17 0.98 0.77 183 5 3.10 1.22 1.19 0.69 124 62.78 1.14 1.05 0.59 152 7 3.11 1.10 1.10 0.91 181 8 2.96 1.12 1.08 0.76133 Average 3.11 1.13 1.12 0.86 144

As shown in Tables 1 and 2, the fluid collector 816, according to anembodiment of the invention, on average collects an amount of fluidsamples in excess of the amounts required for testing and/or retentionin approximately ninety (90)-one hundred fifty (150) seconds. A widerange of collection amounts are anticipated, depending upon the testingrequirements, without detracting from the spirit of the invention.

The housing 801 includes a sample receiving member 818 to receive thefluid collector 812. In one embodiment of the invention, the samplereceiving member 818 includes two collection chambers 874 to receive thetwo-pronged fluid collector 812 through two openings 870, thus forming asplit sample. The sample receiving member 818 is in fluid communicationwith a fluid sample retention member, such as a confirmation collectionchamber 810, and a test cartridge member 804. The test cartridge member804 includes a test cartridge chamber 850; a test cartridge 852; atleast one membrane test strip 806 located on the test cartridge 852 toindicate the presence or absence of at least one analyte; and a testcartridge fluid reservoir 808 in fluid communication with the testcartridge 852 and the sample receiving member 818. In one embodiment ofthe invention, the housing 801 includes windows on the front, back orboth sides of the housing 801 for viewing of the membrane test strip806. A wide variety of housings 801 may be implemented withoutdetracting from the spirit of the invention, including but not limitedto forming the housing 801 from a clear material allowing the membranetest strips 806 to be viewed without a window. The test cartridge fluidreservoir 808 may be formed in a variety of shapes without detractingfrom the spirit of the invention, including a v-shaped chamber with aflat bottom 902 as shown in FIG. 28. The test cartridge fluid reservoir808 with a flat bottom v-shaped chamber 902 allows the test cartridge852 and membrane test strips 806 to fully engage the fluid sample whilemaintaining a small volume of the fluid sample. In one embodiment of theinvention, the v-shaped chamber with a flat bottom 902 forms a volume ofless than seven hundred (700) microliters. An opening 904 at the bottomof the second collection chamber 874 is in fluid connection via achannel 910 with the test cartridge fluid reservoir 808. A wide varietyof connection mechanisms may be implemented to connect the secondcollection chamber 874 and the test cartridge fluid reservoir 808without detracting from the spirit of the invention, including but notlimited to, tubes, piping, channels molded or carved into the housing801, or any other suitable structure.

In one embodiment of the invention, the sample receiving member 818includes a first collection chamber 874 in fluid communication with theconfirmation collection chamber 810 and a second collection chamber 874in fluid communication with the test cartridge member 804. The firstcollection chamber 874 and the confirmation collection chamber 810 arenot in fluid communication with any other elements or components of thehousing 801, including the second collection chamber 874 and the testcartridge member 804. The second collection chamber 874 is in fluidcommunication with the test cartridge fluid reservoir 808, which is influid communication with the test cartridge 852 and the membrane teststrips 806.

Once the fluid collector 812 receives a fluid sample from a testsubject, the fluid collector 812 is inserted into the two collectionchambers 874 in the sample receiving member 818, through two openings870. The fluid sample is expelled by compressing the collector 816between the compression member 890 of both prongs against the bottomsurface of the lower portion of the two collection chambers 874, therebyreleasing the entrapped fluid into the housing 801. The fluid samplefrom the test subject is delivered from the first collection chamber 874to the confirmation collection chamber 810 and from the secondcollection chamber 874 to the test cartridge fluid reservoir 808. Thefluid sample is only obtained a single time with the multiple ortwo-prong fluid collector 812 while maintaining fluid sample integritythrough the collection, storage and analysis of the fluid sample withtwo distinct storage areas: the confirmation collection chamber 810 andthe test cartridge fluid reservoir 808. Once the fluid collector 812 issecured within the housing 801, the fluid sample from the confirmationcollection chamber 810 is not in fluid communication with the fluidsample in the test cartridge fluid reservoir 808. The confirmationcollection chamber 810 fluid sample may be accessed by a third party aspreviously disclosed, typically subsequent to the testing of the fluidsample in the test cartridge fluid reservoir 808. In one embodiment ofthe invention, the confirmation collection chamber 810 is located belowthe first collection chamber 874. In another embodiment of theinvention, the confirmation collection chamber is removable from thehousing 801 after the fluid sample is extracted from the collector 812.The fluid collector 812 secures the fluid sample within the samplereceiving member 818 with the sealing members 880 to form a seal betweenthe fluid collector and the fluid collection chambers 874. In oneembodiment, each prong of the fluid collector 812 includes sealingmembers 880 located near the top and bottom of the upper segment 820 toseal both of the two collection chambers 874. The sealing members 880include sealing rings. The sealing rings may be attached at locationsclose to the top and bottom of the upper segment 820. Generally, thedimensions of sealing members 880, and the sealing rings 28, comportwith the interior dimension of the two collection chambers 874 in orderto prevent the sample from escaping through the openings 870.Additionally, the fluid collector 812 is secured by the locking closuremember 814. In one embodiment of the invention, the locking closuremember 814 includes at least one projection extending from the fluidcollector 812 that cooperates with the at least one projection locatedon the inner surface of the sample receiving member 818, where suchprojections may include for example at least one locking tab and/or atleast one annular ring. According to one embodiment of the invention, aclosure member on the fluid collector 812 may form a sufficiently secureclosure as to constitute means for securing the fluid collector 812within the sample receiving member 818.

The test cartridge 852 includes slots for one or more membrane teststrips 806. In one embodiment of the invention, the test cartridge 852includes locations or slots for membrane test strips 806 on both thefront and back of the test cartridge 852 in a back-to-back formation.The test cartridge 852 may include multiple locations for the membranetest strips 806 on either the front, back or both sides of the testcartridge 852. The test cartridge 852 may allow for a wide number ofmembrane test strips 806 to be attached to the test cartridge withoutdetracting from the spirit of the invention, including but not limitedto, six (6), twelve (12), or twenty-four (24) membrane test strips 806.A wide variety of attachment mechanism may be used to attach themembrane test strips 806 to the test cartridge 852 without detracting tothe spirit of the invention, including but not limited to, slottedmembrane test strip holders 898 on the test cartridge 852 and aprotective sheet attached to the test cartridge 852 that covers andimpedes movement of the test strip 806 from the test strip holders 898.After the membrane test strips 806 are attached to the test cartridge852, the test cartridge 852 is inserted into the test cartridge chamber850 through a test cartridge chamber opening 872 and is placed betweentest cartridge guides 906 on both ends of the test cartridge chamber850. In one embodiment of the invention, the membrane test strips 806extend beyond the test cartridge 852 into the test cartridge fluidreservoir 808. A test cartridge cap 802 is then inserted into the testcartridge chamber 850 to secure the test cartridge 852 within thehousing 801. In one embodiment of the invention, the test cartridge cap802 is fixedly attached to the test cartridge 852 prior to insertioninto the test cartridge chamber 850 or the test cartridge cap 802 andthe test cartridge 852 are formed from a continuous material. In anotherembodiment of the invention, the test cartridge cap 802 attaches to atop edge of the test cartridge chamber opening 872. Advantageously,different versions of the test cartridge 852 may be developed to testdifferent combinations of analytes, thereby allowing the testadministrator to select the appropriate analyte test suite at the testsite. The test cartridge chamber 850, the test cartridge cap 802, or acombination of both may include a locking mechanism known to thoseskilled in the art to secure the test cartridge 852 within the testcartridge chamber 850, thereby preventing the removal of the testcartridge 852 from housing 801.

In one embodiment of the invention, the test strips 806 may indicategenomic or proteomic information such that certain DNA sequences orproteins may be detected that are genetic predispositions for certaindiseases such as various forms of cancer, diabetes, etc.

The test cartridge 852 and test cartridge cap 802 may be made from avariety of materials without detracting from the spirit of theinvention, including but not limited to, plastic, ceramic, metal, glass,wood, rubber, polymer, fiber-reinforced polymer, or any combinationthereof. In one embodiment, the test cartridge 852 is formed fromplastic and is approximately 70 millimeters in height, 40 millimeters inwidth, and 5 millimeters in thickness.

After the fluid sample has been expelled from the fluid collector 812into the test cartridge fluid reservoir 808, the fluid sample encountersthe proximal end of the membrane test strip 806 and begins to moveupward towards the upper end of the membrane test strip 806 by capillaryaction. Each membrane test strip 806 generally indicates the presence orabsence of at least one analyte. A single drug, or class of drugs, isindicated by each membrane test strip 806, including without limitation,for example, cocaine (COC), amphetamine (AMP), methamphetamine (mAMP),marijuana (THC), methadone (MTD), phencyclidine (PCP), morphine,barbiturates, benzodiazepines, or alcohol. In one embodiment, the teststrips 806 may be lateral flow test strips.

In one embodiment, the test cartridge chamber 850 and/or the testcartridge fluid reservoir 808 may be attached to an electrical devicethat supplies an electric current to the fluid sample. The electricalcurrent may be used to separate elements within the fluid sample priorto testing of the fluid sample.

The housing may include an immunoassay-based fingerprint acquisition pad860 to positively identify an individual associated with the fluidcollection and analyte test. In one embodiment of the invention, thesecond collection chamber and/or the test cartridge fluid reservoir 808may be in fluid communication with the immunoassay-based fingerprintacquisition pad 860. The immunoassay-based fingerprint acquisition pad860 may be removably connected to the housing 801 or fixedly attached tothe housing 801. The immunoassay-based fingerprint acquisition pad 860is enclosed by a cover 866 that is held closed by closure member 864 andpivots into the opened position on the axis defined by the hinges 862.The door 866 may be secured after the fingerprint of the test subjecthas been acquired, using various locking mechanisms, including withoutlimitation a tab-and-slot arrangement, or security tape.

The immunoassay-based fingerprint acquisition pad 860 may be astand-alone apparatus connected to the housing 801 or theimmunoassay-based fingerprint acquisition pad 860 may be in fluidcommunication with the test cartridge fluid reservoir 808. Theimmunoassay-based fingerprint acquisition pad 860 in fluid communicationwith the test cartridge fluid reservoir 808 functions as previouslydisclosed.

In an embodiment of the invention, the immunoassay-based fingerprintacquisition pad 860 includes a compressible, porous reaction medium,having a control zone and a plurality of reaction zones, arranged on aporous support. The control zone includes a control reagent to identifythe fluid sample donor, and each reaction zone includes a reactionreagent to determine the presence of a specific analyte in the fluidsample. The control reagent includes a member of a predeterminedligand/receptor binding pair. Similarly, each reaction reagent includesa member of a predetermined ligand/receptor binding pair. Variousligand/receptor binding pairs for use within the control and reactionzones are discussed within the '863 and '815 patents.

In an embodiment of the invention, the immunoassay-based fingerprintacquisition pad 860 is fluidicly coupled to the collection chamber 874.A signal-producing agent, located on upper surface of the porous supportor the lower surface of the reaction medium, mixes with the fluid sampleprovided to the immunoassay-based fingerprint acquisition pad 860. Theproduction of an image or pattern which identifies the person providingthe sample is accomplished by applying a fingertip to the upper surfaceof the reaction medium and compressing the reaction medium so that thefluid sample/signal-producing agent mixture permeates the reactionmedium, and allowing the control zone ligand/receptor reaction to takeplace so that the members of this immunological pair bond with thesignal-producing agent and produce the fingerprint image. Similarly, thepresence or absence of a specific analyte in the fluid sample isindicated within each reaction zone by the reaction of each specificreaction reagent with the fluid sample/signal-producing agent mixture.

Although the invention is described herein with reference to specificembodiments, various modifications and changes can be made withoutdeparting from the scope of the invention as set forth in the claimsbelow. The combination of embodiments is expressly anticipated, unlessthe embodiments and specifically mutually exclusive. A claimed inventionmay include multiple embodiments as disclosed herein. Accordingly, thespecification and figures are to be regarded in an illustrative ratherthan a restrictive sense, and all such modifications are intended to beincluded within the scope of the invention. Any benefits, advantages, orsolutions to problems that are described herein with regard to specificembodiments are not intended to be construed as a critical, required, oressential feature or element of any or all the claims.

From time-to-time, the invention is described herein in terms of theseexample embodiments. Description in terms of these embodiments isprovided to allow the various features and embodiments of the inventionto be portrayed in the context of an exemplary application. Afterreading this description, it will become apparent to one of ordinaryskill in the art how the invention can be implemented in different andalternative environments. Unless defined otherwise, all technical andscientific terms used herein have the same meaning as is commonlyunderstood by one of ordinary skill in the art to which this inventionbelongs.

The preceding discussion is presented to enable a person skilled in theart to make and use the invention. The general principles describedherein may be applied to embodiments and applications other than thosedetailed below without departing from the spirit and scope of theinvention as defined by the appended claims. The invention is notintended to be limited to the embodiments shown, but is to be accordedthe widest scope consistent with the principles and features disclosedherein.

In addition, while a particular feature of the invention may have beendisclosed with respect to only one of several embodiments, such featuremay be combined with one or more other features of the other embodimentsas may be desired. It is therefore, contemplated that the claims willcover any such modifications or embodiments that fall within the truescope of the invention.

The various diagrams may depict an example architectural or otherconfiguration for the invention, which is done to aid in understandingthe features and functionality that can be included in the invention.The invention is not restricted to the illustrated example architecturesor configurations, but the desired features can be implemented using avariety of alternative architectures and configurations. Indeed, it willbe apparent to one of skill in the art how alternative functional,logical or physical partitioning and configurations can be implementedto implement the desired features of the invention. In addition, amultitude of different constituent module names other than thosedepicted herein can be applied to the various partitions. Additionally,with regard to flow diagrams, operational descriptions and methodclaims, the order in which the steps are presented herein shall notmandate that various embodiments be implemented to perform the recitedfunctionality in the same order unless the context dictates otherwise.

Terms and phrases used in this document, and variations thereof, unlessotherwise expressly stated, should be construed as open ended as opposedto limiting. As examples of the foregoing: the term “including” shouldbe read as meaning “including, without limitation” or the like; the term“example” is used to provide exemplary instances of the item indiscussion, not an exhaustive or limiting list thereof; the terms “a” or“an” should be read as meaning “at least one”, “one or more” or thelike; and adjectives such as “conventional”, “traditional”, “normal”,“standard”, “known” and terms of similar meaning should not be construedas limiting the item described to a given time period or to an itemavailable as of a given time, but instead should be read to encompassconventional, traditional, normal, or standard technologies that may beavailable or known now or at any time in the future. Likewise, wherethis document refers to technologies that would be apparent or known toone of ordinary skill in the art, such technologies encompass thoseapparent or known to the skilled artisan now or at any time in thefuture.

A group of items linked with the conjunction “and” should not be read asrequiring that each and every one of those items be present in thegrouping, but rather should be read as “and/or” unless expressly statedotherwise. Similarly, a group of items linked with the conjunction “or”should not be read as requiring mutual exclusivity among that group, butrather should also be read as “and/or” unless expressly statedotherwise. Furthermore, although items, elements or components of theinvention may be described or claimed in the singular, the plural iscontemplated to be within the scope thereof unless limitation to thesingular is explicitly stated.

The presence of broadening words and phrases such as “one or more”, “atleast”, “but not limited to” or other like phrases in some instancesshall not be read to mean that the narrower case is intended or requiredin instances where such broadening phrases may be absent. The use of theterm “module” does not imply that the components or functionalitydescribed or claimed as part of the module are all configured in acommon package. Indeed, any or all of the various components of amodule, whether control logic or other components, can be combined in asingle package or separately maintained and can further be distributedacross multiple locations.

Unless stated otherwise, terms such as “first” and “second” are used toarbitrarily distinguish between the elements such terms describe. Thus,these terms are not necessarily intended to indicate temporal or otherprioritization of such elements.

Additionally, the various embodiments set forth herein are described interms of exemplary block diagrams, flow charts and other illustrations.As will become apparent to one of ordinary skill in the art afterreading this document, the illustrated embodiments and their variousalternatives can be implemented without confinement to the illustratedexamples. For example, block diagrams and their accompanying descriptionshould not be construed as mandating a particular architecture orconfiguration.

All publications and patents mentioned in the above specification areherein incorporated by reference. Various modifications and variationsof the described method and system of the invention will be apparent tothose skilled in the art without departing from the scope and spirit ofthe invention. Although the invention has been described in connectionwith specific preferred embodiments, it should be understood that theinvention as claimed should not be unduly limited to such specificembodiments. Indeed, various modifications of the described modes forcarrying out the invention which are obvious to those skilled in thefield or any related fields are intended to be within the scope of thefollowing claims.

One skilled in the art will recognize that different embodiments may beformed in a similar manner having different characteristics dependingupon need, performance, or some other criteria. It will thus beappreciated by those skilled in the art that changes could be made tothe embodiments described above without departing from the broadinventive concept thereof. It is understood, therefore, that theinvention disclosed herein is not limited to the particular embodimentsdisclosed, but it is intended to cover modifications within the spiritand scope of the present invention as defined by the appended claims.

Although this invention has been described in conjunction with specificembodiments thereof, many alternatives, modifications and variationswill be apparent to those skilled in the art. Accordingly, theembodiments of the invention as set forth herein are intended to beillustrative, not limiting. Various changes may be made withoutdeparting from the true spirit and full scope of the invention as setforth herein.

What is claimed is:
 1. An apparatus for testing a fluid samplecomprising: a sample receiving member having an opening for receiving afluid sample; and a test cartridge member in fluid communication withthe sample receiving member, to indicate the presence or absence of atleast one analyte in the fluid sample; wherein the test cartridge membercomprising a test cartridge further comprising a front set of test stripslots and a back set of test strip slots.
 2. The apparatus of claim 1,wherein the test cartridge comprises at least one test strip located inthe test strip slots.
 3. The apparatus of claim 2, wherein the testcartridge member comprises test cartridge chamber and a test cartridgefluid reservoir in fluid communication with the sample receiving member,wherein the test cartridge is inserted into the test cartridge chamberand wherein the at least one test strip is in fluid communication withthe test cartridge fluid reservoir.
 4. The apparatus of claim 3, whereinthe test cartridge fluid reservoir is a v-shaped chamber with a flatbottom.
 5. The apparatus of claim 4, wherein the v-shaped chamber with aflat bottom forms a volume of less than or equal to four hundred eighty(480) microliters.
 6. The apparatus of claim 3, wherein the testcartridge is inserted into the test cartridge member.
 7. The apparatusof claim 3, wherein a plurality of test strips are inserted into thefront and back sets of test strip slots and wherein the plurality oftest strips are in fluid communication with the test cartridge fluidreservoir.
 8. The apparatus of claim 7, wherein the front set of teststrip slots comprise at least six test strip slots and wherein the backset of test strip slots comprise at least six test strip slots.
 9. Theapparatus of claim 1, wherein the test cartridge member comprises a capto secure the test cartridge.